NCT06888687

Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.

Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Australian Catholic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A parallel, single-blinded, randomised clinical trial conducted remotely across Australia from the Mary MacKillop Institute for Health Research (MMIHR, Australian Catholic University) for individuals with type 2 diabetes, by researchers from Australian Catholic University, University of Adelaide, University of Queensland, University of Wollongong, Monash University, Monash Partners, Deakin University, La Trobe University and Melbourne University.

Detailed description

In a parallel groups design, a total of 156 individuals will be recruited. After baseline pathology (HbA1c), blinded (Libre Pro iQ) continuous glucose monitoring (CGM) data and questionnaires (via REDCap) have been collected, participants will be randomised into one of two groups (DIET, dietetic support only; CGMD, CGM plus dietetic support). All participants will receive four (4) dietetic consults via telehealth at weeks 2, 6, 10 and 16, the content of which will be related to the randomised condition. Measurements will be repeated at 3 and 6 months from baseline to assess the changes in primary and secondary outcomes.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Continuous Glucose Measurement
• Dietary Modification

Interventions

Type	Name	Description
BEHAVIORAL	Dietetic support	Dietary advice will be provided by Accredited Practicing Dietitians (APDs) in line with evidence-based guidelines, specifically the T2DM best-practice guidelines plus Australian Dietary Guidelines (i.e. Australian Guide to Healthy Eating) to improve diet quality, and strategies to promote adherence.
DEVICE	Continuous glucose monitoring	Abbott FreeStyle Libre 2+ CGM sensors will be used to provide feedback on interstitial glucose concentrations over 15 day periods per sensor.

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-11-28
• Completion: 2026-11-28
• First posted: 2025-03-21
• Last updated: 2025-05-23

Locations

1 site across 1 country: Australia